Tele-education in Patients With a Moderate Depressive Episode in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- medication adherence
研究概览
简要总结
Considering that one out of five people may experience depression during the course of their life, and that compliance to anti-depression medication is often not optimal.
Psycho-educational interventions are recommended in international clinical practice guidelines for the management of depression. They are the first step in the treatment protocol.
Psychoeducation in the treatment of depressive episodes has been shown to be an effective intervention because it reduces depressive symptoms, the risk of relapse or recurrence and improves adherence to treatment.
In France, there are only one approved psycho-education programme, but it concerns a population of patients under psychiatric care.
No psycho-education programme has yet been carried out or evaluated in France on depressed patients followed up in primary care by their General Practitioner.
Recent changes in our healthcare practices, which have required adaptation to the pandemic context, have led to the development of the use of telemedicine.
This study aims to evaluate a new and 100% remote educational program adapted to patients ongoing moderate depression and focused on medication adherence, economic gain and patients and professional satisfaction.
详细描述
In addition to the usual standard care, recruited patients will benefit from either an individual tele-education programme or standard care following the randomisation.
The psycho-education programme is based on 3 dimensions: educational (nature of the information and how it should be delivered), psychological (revelation of the diagnosis and transmission of information in a personalised way), behavioural and cognitive (restoring the skills and mobilising the resources of the subject in their daily functioning and in their relationship with the disease (management of treatment and communication skills in particular).
A low number of sessions has been chosen, as it is more appropriate for this population, whose disorders are not severe and who do not require specialist care. The emphasis was placed on personalising the information, with one-to-one sessions.
The tele-education program consists of 5 sessions and is designed to adapt to changes in depressive symptoms over time. Each session will last an average of 60 minutes. They will be scheduled every week for 5 weeks.
The first session is devoted to educational diagnosis, with identification of the patient's needs and any barriers to treatment, in order to personalise the information to be provided about the programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting a depressive episode of moderate intensity according to the Diagnostic and Statistical Manual (DSM)-V
- •With a prescription for an antidepressant started less than 2 months before inclusion in the trial.
- •Whose state of health is compatible with follow-up by their GP (possibility of occasional advice from a psychiatrist).
- •Have Internet access at home (computer) and are able to use the digital platform.
排除标准
- •Patients who are unable to complete self-questionnaires (language barrier, etc.)
- •Who have already undergone a psycho-education or therapeutic patient education programme regarding depression.
- •Whose state of health requires follow-up by a psychiatrist
研究组 & 干预措施
psychoeducation program group
In addition to the usual treatment, the experimental group will receive a tele-education programme on depression in 5 individual remote sessions. During these sessions, the symptoms of the illness will be discussed, as well as health and diet measures, the destigmatisation of the illness, mobilisation of family and friends, the various treatments for depression and, finally, an assessment of what has been learned, which will be sent to the general practitioner with the patient's agreement.
干预措施: psychoeducative program (Other)
control group
The control group will receive their usual care from their GP. An educational booklet on depression will be provided to patients at the start of the study.
结局指标
主要结局
medication adherence
时间窗: 6 months post inclusion
The primary endpoint will be measured by the rate of maintenance on continuous antidepressant medication at 6 months after inclusion in the study. This maintenance rate will be measured using healthcare reimbursement data to reconstruct exposure to antidepressant medication at 6 months following inclusion in the study.
次要结局
- Effectiveness of the tele-education(3 months post inclusion)